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Celcuity (CELC) investor relations material
Celcuity Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Executive summary
Achieved statistically significant and clinically meaningful improvements in both primary endpoints for the PIK3CA wild-type cohort in the Phase 3 VIKTORIA-1/VICTORIA-one trial for HR+/HER2- advanced breast cancer, with gedatolisib reducing risk of progression or death by 76% and significant PFS improvements.
Enrollment ongoing for PIK3CA mutant cohort and additional pivotal trials; topline data for mutant cohort expected in Q4 2025.
First patient dosed in Phase 3 VIKTORIA-2/VICTORIA-two trial for first-line HR+/HER2- ABC; favorable early results in prostate and breast cancer studies.
Issued new patent for gedatolisib dosing regimen, extending exclusivity to 2042.
Raised over $286M through equity, convertible notes, and warrant offerings to fund operations and clinical development.
Financial highlights
Q2 2025 net loss was $45.3M ($1.04/share), up from $23.7M ($0.62/share) in Q2 2024; non-GAAP adjusted net loss was $40.5M ($0.93/share) vs. $22.2M ($0.58/share) year-over-year.
R&D expenses rose to $40.2M from $22.5M, mainly due to increased personnel, trial costs, and a $5M milestone payment to Pfizer.
General and administrative expenses increased to $3.8M, reflecting higher personnel and professional fees.
Ended Q2 with $168.4M in cash and equivalents; pro forma including Q3 financing, cash position is $455M.
Interest expense for the quarter was $3.2M, up 42% year-over-year due to increased debt.
Outlook and guidance
NDA submission for gedatolisib planned for Q4 2025; topline data for PIK3CA mutant cohort also expected in Q4 2025.
Cash, investments, and available borrowings expected to fund operations and commercialization through 2027.
Anticipated increases in R&D and G&A expenses as clinical programs expand and commercialization preparations accelerate.
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